ZYVOX® How Supplied/Storage and Handling

(linezolid)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Injection

ZYVOX I.V. Injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are not made with natural rubber latex. The infusion bags are available in the following package sizes:

200 mg/100 mL (2 mg/mL) linezolid × 10

NDC 0009-5137-04

600 mg/300 mL (2 mg/mL) linezolid × 10

NDC 0009-5140-04

16.2 Tablets

ZYVOX Tablets are available as follows:

600 mg (white, capsule-shaped, film-coated tablets debossed with "ZYV" on one side and "600" on the other)

20 tablets in HDPE bottle

NDC 0009-5138-02

Unit dose packages of 30 tablets

NDC 0009-5138-03

16.3 Oral Suspension

ZYVOX for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. ZYVOX for Oral Suspension is supplied as follows:

100 mg/5 mL in 240 mL glass bottles

NDC 0009-5136-01

100 mg/5 mL in 240 mL glass bottles

NDC 0009-5136-04

16.4 Storage and Handling

Store at 25ºC (77ºF). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.

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Health Professional Information

How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Injection

ZYVOX I.V. Injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are not made with natural rubber latex. The infusion bags are available in the following package sizes:

200 mg/100 mL (2 mg/mL) linezolid × 10

NDC 0009-5137-04

600 mg/300 mL (2 mg/mL) linezolid × 10

NDC 0009-5140-04

16.2 Tablets

ZYVOX Tablets are available as follows:

600 mg (white, capsule-shaped, film-coated tablets debossed with "ZYV" on one side and "600" on the other)

20 tablets in HDPE bottle

NDC 0009-5138-02

Unit dose packages of 30 tablets

NDC 0009-5138-03

16.3 Oral Suspension

ZYVOX for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. ZYVOX for Oral Suspension is supplied as follows:

100 mg/5 mL in 240 mL glass bottles

NDC 0009-5136-01

100 mg/5 mL in 240 mL glass bottles

NDC 0009-5136-04

16.4 Storage and Handling

Store at 25ºC (77ºF). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.

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